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Clinical Trials/NCT05756842
NCT05756842Active, not recruitingNot Applicable

The Effect of a Honey-based Gel Supplement From the Wider Area of Pindos on Human Health and Oxidative Stress Biomarkers

University of Thessaly2 sites in 1 country20 target enrollmentStarted: March 6, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
20
Locations
2
Primary Endpoint
Change in glutathione concentration of erythrocytes

Study Overview

Brief Summary

The aim of the present clinical study is to estimate the efficacy of a honey-based gel, derived from the wider area of Pindos in Greece, in regulating oxidative stress biomarkers and the physiological profile of healthy adults.

Detailed Description

Introduction

Honey contains about 200 compounds such as sugars, proteins, vitamins, water, free amino acids, enzymes, minerals, and many phytochemicals. Due to its composition, enriched with many bioactive ingredients, several studies have established its antimicrobial, antiviral, anticancer, antidiabetic and antioxidant properties. This multilayer activity of honey has been proposed for the protection against pathologies interrelated with the cardiovascular, nervous, respiratory, and gastrointestinal system.

Purpose: This study aims to investigate the effects of a novel natural honey-based gel consumption on oxidative stress biomarkers, blood chemistry and physiological characteristics in healthy individuals.

Methodology: A total of 20 healthy men and women will participate in the study. Participants will give their informed consent after they will be informed about the purposes, procedures, risks and benefits associated with the study. Participants will consume 70 g/day of the honey-based gel, distributed in 2 equal doses (in the morning and evening) for 14 days. At baseline and post-intervention, volunteers will be assessed for their physiological profile and will provide a resting blood sample for the assessment of oxidative stress and blood chemistry biomarkers as well as their physiological profile. Participants will be asked to record their diet for 3 days prior to the study and they will be asked to follow the same dietary pattern for 3 days before the post-intervention assessments.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy Individuals aged 18-65 years
  • Non-smokers

Exclusion Criteria

  • Musculoskeletal injury
  • Dietary supplements
  • Medication
  • Allergy in bee pollen

Outcomes

Primary Outcomes

Change in glutathione concentration of erythrocytes

Time Frame: Change from baseline to 14 days

Glutathione concentration will be analyzed in erythrocytes by spectrophotometry

Change in total antioxidant capacity of plasma

Time Frame: Change from baseline to 14 days

Total antioxidant capacity will be analyzed in plasma by spectrophotometry

Change in protein carbonyls of plasma

Time Frame: Change from baseline to 14 days

Protein Carbonyls will be analyzed in plasma by spectrophotometry

Change in thiobarbituric acid reactive substances of plasma

Time Frame: Change from baseline to 14 days

Thiobarbituric acid reactive substances will be analyzed in plasma by spectrophotometry

Change in body weight

Time Frame: Change from baseline to 14 days

Body weight will be measured using a digital scale

Change in catalase enzyme activity of erythrocytes

Time Frame: Change from baseline to 14 days

Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry

Change in complete blood count

Time Frame: Change from baseline to 14 days

White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood

Change in body fat

Time Frame: Change from baseline to 14 days

Body fat will be measured by bioelectrical impedance analysis

Change in diastolic and systolic blood pressure

Time Frame: Change from baseline to 14 days

Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer

Change in waist and hip circumference

Time Frame: Change from baseline to 14 days

Waist and hip circumference will be assessed using a tape measure

Change in resting heart rate

Time Frame: Change from baseline to 14 days

Resting heart rate will be measured using a heart rate sensor

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Athanasios Z. Jamurtas

Professor

University of Thessaly

Study Sites (2)

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